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Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide

NCT02638805 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2018-11-05

No results posted yet for this study

Summary

A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in subjects with Type 2 diabetes taking liraglutide and metformin.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

ITCA 650 Osmotic Mini Pump 20/60 mcg/day

ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day

DRUG

ITCA 650 Osmotic Mini Pump 60 mcg/day

ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day

DRUG

Metformin

Stable dose for at least 3 months (at least 1000 mg/day)

DRUG

Liraglutide

Stable dose for at least 3 months (at least 1.2 mg/day)

Sponsors & Collaborators

  • Intarcia Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02638805 on ClinicalTrials.gov